FDA — authorised 30 July 2021
- Application: BLA761123
- Marketing authorisation holder: ASTRAZENECA AB
- Local brand name: SAPHNELO
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Saphnelo in United States
FDA authorised Saphnelo on 30 July 2021
Marketing authorisations
FDA — authorised 24 April 2026
- Application: BLA761451
- Marketing authorisation holder: ASTRAZENECA AB
- Local brand name: SAPHNELO
- Indication: VIAL — SINGLE-USE
- Status: approved
Saphnelo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Saphnelo approved in United States?
Yes. FDA authorised it on 30 July 2021; FDA authorised it on 24 April 2026.
Who is the marketing authorisation holder for Saphnelo in United States?
ASTRAZENECA AB holds the US marketing authorisation.